The Certified Biomedical Auditor is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a biomedical system while using various tools and techniques to examine, question, evaluate, and report on that system's adequacies and deficiencies.
A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.
Here are the requirements, experience and exam specifics for a Certified Biomedical Auditor.
Candidates must have worked in a full-time, paid role. Paid intern, co-op or any other course work cannot be applied toward the work experience requirement.
The CBA requires five years of work experience including one year in a decision-making position. "Decision-making" is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.
Candidates who have completed a degree from a college, university or technical school with accreditation accepted by ASQ will have part of the five-year experience requirement waived, as follows (only one of these waivers may be claimed):
Associate degree — one year waived
Bachelor's degree — three years waived
Master's or doctorate — four years waived
Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.
Here are the minimum expectations of a Certified Biomedical Auditor.
Will be able to differentiate between various audit types and determine the roles and responsibilities of the audit participants, and will be able to respond appropriately to situations in terms of ethical and professional conduct. Will be able to distinguish between audit procedural references, regulatory requirements and guidance, and quality system regulations and standards.
Will be able to identify resource requirements in preparation and planning for an audit and will be able to manage and perform an audit, from the opening meeting to the exit meeting. Will be able to document observations, collect objective evidence, use working papers, and classify nonconformances. Will be able to create an effective audit report, apply record retention requirements, and know when an audit can be closed. Will be able to evaluate corrective and preventive action plans.
Will be able to distinguish between audit procedural references and guidance's (such as ISO 19011 and GHTF SG4) and the FDA Quality System Inspection Technique (QSIT).
Will be able to analyze the effectiveness of a biomedical quality management system in relation to those national and international regulations and standards for production and process controls, document and change control systems, purchasing controls, and product identification and traceability.
Will be able to identify and apply standards related to risk management and hazard detection. Will be able to identify and apply standards related to methods of sterilization for aseptically processed and terminally sterilized products.
Will be able to evaluate risk management programs evaluate requirements for complaint handling, vigilance, medical device reporting (MDR) and tracking, and evaluate product recall processes. Will be able to review validation procedures for laboratory testing and use appropriate methods for analyze, detect and control nonconformances. Will apply appropriate standard driven data analysis and statistical techniques used for sampling.
Will identify and describe biocompatibility terms, associated tests, and test selection rationale in accordance with applicable standards and guidelines. Will be able to evaluate environmental controls and determine whether utilities require qualification, validation, or maintenance.
Will be able to recognize the elements of the software development life cycle for products, processes, and quality systems. Will be able to identify sources for new and evolving standards and guidance documents and recognize common medical device directives and standards.
Will be able to apply quality tools and process improvement techniques using qualitative and quantitative analysis.
Included in the Body of Knowledge are subtext explanations and corresponding cognitive levels for each subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content within each topic that may be tested.
The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam, but is intended to clarify how topics are related to the role of the certified biomedical auditor. The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of the document.
Download the Certified Biomedical Auditor Body of Knowledge
Review a list of references that provide the basis for the exam questions. These items give you a better idea of the material covered in the exam. ASQ offers many books and training opportunities to help you prepare.
ASQ certification examinations are delivered by ASQ's testing partner, Prometric. The examination scheduling instructions in your eligibility letter will direct you to a section of Prometric's website, where you can select and schedule your examination date and location.